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A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) in the United States

RECRUITINGSponsored by Janssen Research & Development, LLC
Actively Recruiting
SponsorJanssen Research & Development, LLC
Started2026-06-12
Est. completion2029-03-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations13 sites

Summary

The purpose of this study is to assess how well TAR-200 works in real-word by measuring the time taken from the first TAR-200 insertion to worsening of cancer or until the signs and symptoms of cancer occur again (disease-free survival) in participants with non-muscle invasive bladder cancer (NMIBC; an early-stage bladder cancer that is limited to the inner lining of bladder).

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion criteria:

* Has a confirmed diagnosis of NMIBC based on TURBT or cold cup biopsy
* Initiated first dose of TAR-200 in a real-world setting within 6 weeks prior to baseline visit/Study visit 1
* Participants with childbearing potential are required to adhere to contraceptive recommendations as specified in the approved product labeling for TAR-200. Additionally, participants should seek consultation with their physician for personalized contraceptive advice
* Must provide informed consent as described in the protocol

Exclusion criteria:

* Has any medical condition deemed by the health care practitioner (HCP) as contraindicated to receive TAR-200 treatment
* Had previous treatment with TAR-200 discontinued prior to baseline visit/Study visit 1
* Previously received TAR-200 intravesically as part of a clinical trial(s)
* Previously received greater than (\>) 2 doses/cycles of TAR-200 in the real-world setting
* Currently participating in an interventional bladder cancer clinical trial

Conditions2

CancerNon-Muscle Invasive Bladder Neoplasms

Locations13 sites

University of Alabama at Birmingham
Birmingham, Alabama, 35294
Arkansas Urology
Little Rock, Arkansas, 72211
USC Norris Comprehensive Cancer Center
Cedars Sinai Medical Center
Colorado Clinical Research
Lakewood, Colorado, 80228

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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